Class I · High risk Ongoing
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals…
Reason Presence of Particulate Matter; identified as stainless steel
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter; identified as stainless steel
What was recalled
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1
- Recalling firm
- Sunny Pharmtech Inc.
- NDC code
- 81298-8112-1
- Origin
- Taiwan
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0743-2026
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Cyclophosphamide recalls
See all
Class II · Moderate risk Ongoing
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in…
Reason cGMP deviations: Temperature excursion during transportation.
Class III · Low risk Terminated
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After…
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration…
Class III · Low risk Terminated
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only…
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration…
Class II · Moderate risk Terminated
Cyclophosphamide 840 MG / 250 ML NS IVPB; Cyclophosphamide 1112 MG / 250 ML NS IVPB; Cyclophosphamide 1248 MG / 50 ML NS IVPB…
Reason Lack of Assurance of Sterility
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